Gestión de calidad y verificación de métodos analíticos en un laboratorio de investigación bajo normativa de Buenas Prácticas de Laboratorio

Abstract

The quality management of the laboratory aims to guarantee the reliability of the measurements that are performed and of each of the processes that are developed in it. Each laboratory must design an internal control system to verify the expected quality of the results. The implementation of a quality management model is regulated by the Good Laboratory Practices and the standards of the ISO 9000 series. These regulations establish the need for systems to comprehensively cover all stages of the research-development cycle, production and marketing. There is an increasing demand for veterinary laboratories that meet international standards to improve reliability. This is of special importance for the laboratories in charge of carrying out preclinical studies for the pharmaceutical industry. Therefore, it is necessary that the laboratories have their techniques validated before using them routinely. In this work the implementation of the GLP quality management of the clinical analysis laboratory of the JUMISC is developed, analyzing and verifying the analytical methods of the different determinations that are carried out (hematology, biochemistry, coagulation and cardiac enzymes) and in the animal species more often used in research (pig, sheep, dog, rabbit and minipig), studying the accuracy and repeatability of the results, ensuring that they are reliable, reproducible and auditable. The results of this work establish requirements and guidelines to follow that will serve as a guide to other veterinary laboratories that will serve as a national and international reference as it ensures quality results.